Actively Recruiting
Comparing Home Blood Pressure Measurements from Validated and Non-validated Devices to Ambulatory Monitoring for Hypertension
Led by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · Updated on 2025-02-14
140
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the accuracy of various blood pressure measuring devices sold online, comparing both validated and non-validated devices against ambulatory blood pressure monitoring (ABPM) in adults with hypertension. The study aims to determine how well these devices measure mean awake blood pressure, providing important information for people managing high blood pressure. Participants will have their blood pressure measured using one validated home blood pressure device and three different non-validated home blood pressure devices. These measurements will then be compared to the average awake blood pressure readings obtained from ambulatory blood pressure monitoring performed immediately after the home device measurements. The study uses a randomized, single-masked design to assign the order of device use. During the study, participants will undergo blood pressure measurements with each device and the ambulatory monitor. Researchers will assess the mean differences in systolic and diastolic blood pressure readings at enrollment. The study focuses on comparing the accuracy of these devices to the ambulatory blood pressure monitor. Participant involvement includes providing consent, attending measurement visits, and allowing blood pressure recordings, with the study continuing until November 2027.
CONDITIONS
Brief Title
Accuracy Testing of Validated and Non-validated Home BP Devices Sold on the Online Market.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged > 18 years scheduled to undergo an ABPM
You will not qualify if you...
- Upper arm size outside of cuff range of selected devices (<22 cm or >42 cm)
- Night shift workers
- Permanent atrial fibrillation
- Known severe aortic stenosis
- Contraindication to measure BP on the non-dominant arm
- Ongoing pregnancy
- Inability or unwillingness to provide consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At enrollment (time 0)
Participants have their blood pressure measured using different home BP devices and undergo awake ambulatory blood pressure monitoring (ABPM) for comparison.
1 baseline visit (in-person)
Duration - Up to completion of study
Participants' blood pressure measurements from home devices are compared with ABPM results to assess accuracy over time.
Additional assessments may occur depending on cohort assignment
Trial Site Locations
Total: 1 location
1
Hôpital Sacré-Coeur de Montréal
Montreal, Quebec, Canada, H4J 1C5
Actively Recruiting
Research Team
R
Remi Goupil, MD MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DIAGNOSTIC
Number of Arms
4
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